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Biotechnology
28 November 2024 Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma.
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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
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Biotechnology
The merger of Israeli gastrointestinal disorders specialist RDD Pharma and US biotech Innovate Biopharmaceuticals has yet to be consummated, but the merged entity’s first proposed acquisition has already been announced. 13 November 2019
Biotechnology
Continuing its battle with the Japanese pharma company, US biotech Seattle Genetics today announced that it has submitted an arbitration demand to the American Arbitration Association to resolve its dispute with Daiichi Sankyo. 13 November 2019
Biotechnology
Danish dermatology specialist Leo Pharma has exercised an option in its collaboration with HitGen, a Chinese company with an early-stage drug discovery platform based on DNA encoded chemical libraries (DELs). 13 November 2019
Biotechnology
Positive results from the pivotal study of Nucala (mepolizumab) in the treatment of patients living with hypereosinophilic syndrome (HES) have been released, making it the first treatment to demonstrate a reduction in flares for this rare disease. 13 November 2019
Biotechnology
Actelion Pharmaceuticals has decided to voluntarily withdraw the European and other health authority filings still under review to extend the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). 13 November 2019
Biotechnology
Genome editing company Editas Medicine has extended a strategic research collaboration with Celgene. 12 November 2019
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for mavorixafor (X4P-001) for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. 12 November 2019
Biotechnology
US biotech companies bluebird bio and Forty Seven have announced a research collaboration. 12 November 2019
Biotechnology
Shares in Boston biotech company Solid Biosciences opened 71% down on Tuesday after the company announced a major setback for its lead candidate. 12 November 2019
Biotechnology
Japan’s NEC Corporation and Vaximm, a Swiss biotech company focused on developing oral T-cell immunotherapies, today announced the signing of a strategic clinical trial collaboration and an equity investment agreement to develop novel personalized neoantigen cancer vaccines. 12 November 2019
Biotechnology
US biotech Reata Pharmaceuticals says it will seek Food and Drug Administration approval for what would be the first drug to reverse kidney damage and prevent the need for dialysis or transplant. 12 November 2019
Biotechnology
More than a year after the TULIP 1 trial of anifrolumab missed its primary endpoint, British drugmaker AstraZeneca announced a more encouraging outcome from the Phase III TULIP 2 study. 12 November 2019
Biotechnology
One year after achieving landmark approval in China for the first ever China-discovered and developed targeted oncology drug to receive unconditional approval (fruquintinib, for colorectal cancer), the Hong Kong-headquartered and Nasdaq-listed Chi-Med is on the way to commercializing its second China-developed drug, this time for advanced non-pancreatic neuroendocrine tumors (NETs). 11 November 2019
Biotechnology
The US Food and Drug Administration has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. 11 November 2019
Biotechnology
New data being presented at the 2019 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in Houston, Texas from November 7-11, showed that Takhzyro (lanadelumab-flyo) injection continued to prevent hereditary angioedema (HAE) attacks at a rate similar to that observed in the pivotal HELP Study, in patients who received treatment for a mean duration of 19.7 (0-26.1) months. 11 November 2019
Biotechnology
Merck KGaA and Pfizer’s hopes of advancing their PD-L1 antibody Bavencio (avelumab) in the challenging gastric cancer space were dealt a blow by the topline results of the Phase III JAVELIN Gastric 100 study. 11 November 2019
Biotechnology
UK and Austria-based biotech F2G has won Breakthrough Therapy designation from the American regulator for its lead first-in-class candidate, olorofim. 11 November 2019
Biotechnology
Swiss pharma giant Roche today announced positive data from the pivotal Part 2 of SUNFISH, a study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). 11 November 2019
Biotechnology
US biotech major Gilead Sciences and Belgium’s Galapagos NV on Saturday announced detailed results from the companies’ clinical research program evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis (RA), which is part of the expanded multi-billion dollar collaboration announced in July. 11 November 2019
Biotechnology
On Friday the US Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. 9 November 2019
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